Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status

JRCT ID: jRCT1030210250

Registered date:18/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Unresectable and/or Metastatic Breast Cancer
• Date of first enrollment: 24/08/2021
• Target sample size: 150
• Countries of recruitment: AUSTRALIA,Japan,CANADA,Japan,GERMANY,Japan,FRANCE,Japan,UNITED KINGDOM,Japan,ITALY,Japan,SOUTH KOREA,Japan,AMERICA,Japan,PORTUGAL,Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: HER2-low prevalence based on local lab rescoring of historical HER2 fixed tissue slides among HER2-neg mBC patients, treatment sequencing, and disease outcomes (TFST, TTF, OS).
• Secondary Outcome: Distribution of patient demographic and clinicopathological characteristics at baseline, and concordance of HER2 IHC scores between historical and local rescoring post-training.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Men or women:
(a) or more 18 years of age when consent provided for future sample and clinical data use - applicable for all countries participating in the study except Japan
(b) or more 20 years of age when consent provided for future sample and clinical data use - applicable for Japan only
2. Must have a histological or cytological confirmed diagnosis of unresectable or/and mBC between 01 January 2015 and 31 December 2017
3. Must have provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use. If the patient is deceased, a waiver may be accepted
4. Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status
5. Progressed on any systemic anti-cancer therapy (eg, ET, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting
6. Must have historical HER2 fixed tissue IHC stained slides (preferably stained using Ventana 4B5 assay) in acceptable quality for accurate rescoring

Exclude criteria

1. Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin
2. Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified

Related Information

• Primary Sponsor: Fujiwara Kosaku
• Secondary Sponsor: AstraZeneca AB
• Secondary ID(s): NCT04807595